TY  - JOUR
AU  - Scuteri, Damiana
AU  - Lawrence, Gary W
AU  - Iannacchero, Rosario
AU  - Trimboli, Michele
AU  - Nicotera, Pierluigi
AU  - Corasaniti, Maria T
AU  - Bagetta, Giacinto
TI  - Efficacy and safety of mAbs anti-CGRP/CGRP R (eptinezumab and erenumab) or atogepant in combination with onabotulinumtoxinA in refractory chronic migraine: a clinical trial protocol.
JO  - Pain management
VL  - 15
IS  - 4
SN  - 1758-1869
CY  - London
PB  - Taylor & Francis
M1  - DZNE-2025-00532
SP  - 177 - 181
PY  - 2025
AB  - Chronic migraine is a disabling neurovascular disorder that represents the leading cause of years lived with disability in people under 50 with a remarkable social burden due to widespread resistance to the front-line treatments used routinely in current clinical practice. The present study investigates the efficacy and safety of combination therapy using eptinezumab and erenumab, recently approved monoclonal antibodies (mAbs) directed against calcitonin gene-related peptide or its receptor, respectively, or the receptor competitive antagonist atogepant together with botulinum toxin type A in chronic migraine that has proven resistant to front-line treatments for at least 6 weeks. To this aim a retrospective and a prospective phase are designed. Furthermore, a feasible salivary biomarker of migraine is under investigation in the prospective stage of the study. Based on recent expert opinions supporting the switch to easy-to-use small molecule calcitonin gene-related peptide (CGRP)-targeting, i.e. rimegepant or atogepant in unresponsive patients, the present study may offer to clinicians a novel treatment to enhance the therapeutic preventive machinery in chronic migraine.
KW  - Migraine Disorders: drug therapy
KW  - Humans
KW  - Botulinum Toxins, Type A: therapeutic use
KW  - Botulinum Toxins, Type A: administration & dosage
KW  - Antibodies, Monoclonal, Humanized: therapeutic use
KW  - Antibodies, Monoclonal, Humanized: administration & dosage
KW  - Antibodies, Monoclonal, Humanized: adverse effects
KW  - Antibodies, Monoclonal, Humanized: pharmacology
KW  - Calcitonin Gene-Related Peptide Receptor Antagonists: therapeutic use
KW  - Calcitonin Gene-Related Peptide Receptor Antagonists: administration & dosage
KW  - Drug Therapy, Combination
KW  - Calcitonin Gene-Related Peptide: antagonists & inhibitors
KW  - Prospective Studies
KW  - Chronic Disease
KW  - Retrospective Studies
KW  - Adult
KW  - Treatment Outcome
KW  - Male
KW  - CGRP receptor antagonists (Other)
KW  - anti-CGRP monoclonal antibodies (Other)
KW  - anti-CGRP-R monoclonal antibodies (Other)
KW  - atogepant (Other)
KW  - chronic migraine (Other)
KW  - gepants (Other)
KW  - onabotulinumtoxinA (Other)
KW  - Botulinum Toxins, Type A (NLM Chemicals)
KW  - erenumab (NLM Chemicals)
KW  - Antibodies, Monoclonal, Humanized (NLM Chemicals)
KW  - Calcitonin Gene-Related Peptide Receptor Antagonists (NLM Chemicals)
KW  - eptinezumab (NLM Chemicals)
KW  - onabotulinum toxin A (NLM Chemicals)
KW  - Calcitonin Gene-Related Peptide (NLM Chemicals)
LB  - PUB:(DE-HGF)16
C6  - pmid:40169386
DO  - DOI:10.1080/17581869.2025.2487413
UR  - https://pub.dzne.de/record/278022
ER  -